Chlorhexidine Diacetate EP Impurity B CAS 1308292-89-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1308292-89-8
Molecular FormulaC16H26ClN9O
Molecular Weight395.89 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Chlorhexidine Diacetate EP Impurity B CAS 1308292-89-8 chemical structure

Description

CATO supplies Chlorhexidine Diacetate EP Impurity B (CAS 1308292-89-8), a pharmacopoeial impurity reference standard (molecular formula C16H26ClN9O, MW 395.89 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Chlorhexidine Diacetate EP Impurity B (C16H26ClN9O) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 8.0, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 395.89 g/mol, it falls into the moderately-high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC16H26ClN9O
Molecular Weight395.89 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1990
Halogen ContentCl-containing
Nitrogen Atoms9

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